Customizable wound closure device and method of use

ABSTRACT

A negative pressure wound closure system and methods for using such a system are described. Preferred embodiments of the invention facilitate closure of the wound by preferentially contracting to provide for movement of the tissue. Some embodiments may include wound closure devices built from smaller units that are modular, assemble-able and/or customizable.

BACKGROUND Field

This application describes embodiments of apparatuses, methods, andsystems for the treatment of wounds, specifically to aid in the closureof large wounds, in conjunction with the administration of negativepressure.

Description of the Related Art

Negative pressure wound therapy has been used in the treatment ofwounds, and in many cases can improve the rate of healing while alsoremoving exudates and other deleterious substances from the wound site.

Abdominal compartment syndrome is caused by fluid accumulation in theperitoneal space due to edema and other such causes, and results ingreatly increased intra-abdominal pressure that may cause organ failureeventually resulting in death. Causes may include sepsis or severetrauma. Treatment of abdominal compartment syndrome may require anabdominal incision to permit decompression of the abdominal space, andas such, a large wound may be created onto the patient. Closure of thiswound, while minimizing the risk of secondary infections and othercomplications, and after the underlying edema has subsided, then becomesa priority. However, acute open abdominal conditions may be caused byother reasons in addition to compartment syndrome, as described furtherbelow.

Other large or incisional wounds, either as a result of surgery, trauma,or other conditions, may also require closure. For example, woundsresulting from sternotomies, fasciotomies, and other abdominal woundsmay require closure. Wound dehiscence of existing wounds is anothercomplication that may arise, possibly due to incomplete underlyingfascial closure, or secondary factors such as infection.

Existing negative pressure treatment systems, while permitting eventualwound closure, still require lengthy closure times. Although these maybe combined with other tissue securement means, such as sutures, thereis also a risk that underlying muscular and fascial tissue is notappropriately reapproximated so as to permit complete wound closure.Further, when foam or other wound fillers are inserted into the wound,the application of negative pressure to the wound and the foam may causeatmospheric pressure to bear down onto the wound, compressing the foamdownward and outward against the margins of the wound. This downwardcompression of the wound filler slows the healing process and slows orprevents the joining of wound margins. Additionally, inflammation of thefascia in the form of certain types of fasciitis can lead to rapid andexcessive tissue loss, potentially meriting the need for more advancednegative pressure treatment systems.

Further, because wounds are of different shapes and/or sizes, foam orother wound fillers may need to be sized or shaped to better accommodatewounds. Although existing foam or other wound fillers may be cut or tearto certain size or shape, the adjustment may be limited by variousfactors, such as the size or the shape of the original foam or otherwound fillers. Additionally, a wound may change its size or shape asnegative pressure treatment continues. Accordingly, there is a need toprovide for an improved apparatus, method, and system for the treatmentand closure of wounds.

SUMMARY

Embodiments of the present invention relate to negative pressure woundclosure devices, methods of making the same, and methods and systemsthat facilitate closure of a wound. It will be understood by one ofskill in the art that the wounds described herein this specification mayencompass any wound, and are not limited to a particular location ortype of wound. The devices, methods, and systems may operate to reducethe need for repetitive replacement of wound filler material currentlyemployed and can advance the rate of healing. The devices, methods, andsystems may be simultaneously used with negative pressure to removewound fluids.

In some embodiments, a wound closure device may comprise a plurality ofbuilding blocks and/or building units configured to be adhered to orattached to each other to form an assembled structure for insertion intoor placement over a wound.

In some embodiments, each of the building blocks and/or building unitsmay comprise at least one cell. The building blocks and/or buildingunits may be configured to form an assembled stabilizing structurecomprising a plurality of cells defined by one or more walls, wherein inthe assembled stabilizing structure cells are provided side-by-side in ahorizontal plane and each of the cells has a top end and a bottom endwith an opening extending through the top and bottom ends.

In some embodiments, the plurality of building blocks and/or buildingunits may be configured to be reversibly adhered to one another. One ormore of the building blocks and/or building units may compriseattachment elements and/or receiving elements configured to receiveattachment elements of one or more of the building blocks and/orbuilding units.

In some embodiments, one or more of the building blocks and/or buildingunits may have an elongate shape with a uniform width. Each buildingunits may comprise one or more cells provided in a single row. Each ofbuilding units may have a uniform width. Each of the building units maybe configured to reduce or increase its length by removing or addingcells respectively.

In some embodiments, each of the building blocks and/or building unitsmay comprise cells having a uniform shape and size. Each of one or morebuilding blocks may consist of one cell. Each of the building blocksand/or building units may comprise at least one cell having atriangular, quadrilateral or hexagonal shape.

In some embodiments, each of the building blocks and/or building unitscomprises foam or porous material. One or more building blocks and/orbuilding units may further comprise precuts defining frangible portionsof the foam or porous material. One or more of the plurality of buildingblocks and/or building units may be configured to be cut or torn.

In some embodiments, the wound closure device may further comprise asource of negative pressure, a drape and/or an organ protection layer.The wound closure device may further comprise a port configured totransmit negative pressure through a drape placed over the wound.

In certain embodiments, a method of treating a wound comprises:

-   -   adhering a plurality of building blocks and/or building units to        one another to provide a stabilizing structure;    -   inserting the stabilizing structure into the wound;    -   wherein the plurality of building blocks and/or building units        comprise one or more cells,    -   wherein the plurality of building blocks and/or building units        are configured to be adhered to one another to provide the        stabilizing structure.

In some embodiments, the method may further comprise adjusting the sizeand/or shape of the building blocks and/or the building units,optionally by detaching one or more cells from one or more units,wherein one or more units have two or more cells. The method may furthercomprise providing a plurality of building units having a uniform sizeand shape, and subsequently adjusting the size and/or shape of each ofthe plurality of building units having the uniform size and shape. Themethod may further comprise detaching one or more building blocks and/orthe building units from the stabilizing structure, wherein the pluralityof building blocks and/or the building units are detachably adhered.

In some embodiments, the method may further comprise covering thestabilizing structure with a drape sealed to skin surrounding the wound;and applying negative pressure through the drape to the wound via asource of negative pressure, wherein the application of negativepressure causes the stabilizing structure to horizontally collapse. Themethod may further comprise inserting a tissue protection layer over thewound before inserting the stabilizing structure.

Other embodiments of wound closure devices, stabilizing structures andassociated apparatuses and methods are described below.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be apparentfrom the following detailed description of the invention, taken inconjunction with the accompanying drawings of which:

FIG. 1 illustrates an embodiment of a negative pressure treatmentsystem.

FIG. 2 illustrates an embodiment of a stabilizing structure.

FIG. 3 illustrates an embodiment of an open abdominal wound.

FIG. 4 illustrates an embodiment of a step in a method of treating awound.

FIG. 5 illustrates an embodiment of a step in a method of treating awound.

FIGS. 6A-B illustrate an embodiment of steps of a method of treating awound.

FIGS. 7A-B are photographs of steps of a method of treating a wound.

FIGS. 8A-C depict an embodiment of steps of a method of treating awound.

FIG. 9 contains photographs of embodiments of steps of a method oftreating a wound.

FIGS. 10A-G illustrate an embodiment of a method of treating a wound.

FIGS. 11A-C illustrate an embodiment of assembling a wound closuredevice.

FIG. 12 illustrates an embodiment of a structure used to assemble awound closure device.

FIGS. 13A-C illustrate embodiments of units used to assemble a woundclosure device and a method of providing them.

FIGS. 13D-E illustrate an embodiment of a method of assembling a woundclosure device.

FIG. 13F illustrates an embodiment of a wound closure device provided bythe method illustrated by FIGS. 13D-E.

FIGS. 14A-D illustrate embodiments of units used to assemble a woundclosure device and a method of providing them.

FIG. 14E illustrates an embodiment of a wound closure device provided byassembling units illustrated by FIGS. 14A-D.

FIG. 14F illustrates a plan view of the wound closure device of FIG.14E.

FIG. 14G illustrates another embodiment of a wound closure deviceprovided by assembling units illustrated by FIGS. 14A-D.

FIG. 15A illustrates an embodiment of units used to assemble a woundclosure device.

FIG. 15B illustrates an embodiment of a wound closure device provided byassembling units illustrated in FIG. 15A and/or modifications thereof.

DETAILED DESCRIPTION

Embodiments disclosed in this section or elsewhere in this specificationrelate to apparatuses and methods of treating a wound with reducedpressure, including pump and wound dressing components and apparatuses.The apparatuses and components comprising the wound overlay and packingmaterials, if any, are sometimes collectively referred to in thissection or elsewhere in this specification as dressings.

It will be appreciated that throughout this specification reference ismade to a wound. It is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis torn, cut or punctured or where trauma causes a contusion, or anyother superficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, abdominal wounds or other large or incisionalwounds, either as a result of surgery, trauma, sternotomies,fasciotomies, or other conditions, dehisced wounds, acute wounds,chronic wounds, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, burns, electricalburns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, traumaand venous ulcers or the like.

As is used in this section or elsewhere in this specification, reducedor negative pressure levels, such as −X mmHg, represent pressure levelsthat are below standard atmospheric pressure, which corresponds to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly,a negative pressure value of −X mmHg reflects absolute pressure that isX mmHg below 760 mmHg or, in other words, an absolute pressure of(760−X) mmHg. In addition, negative pressure that is “less” or “smaller”than −X mmHg corresponds to pressure that is closer to atmosphericpressure (e.g., −40 mmHg is less than −60 mmHg). Negative pressure thatis “more” or “greater” than −X mmHg corresponds to pressure that isfurther from atmospheric pressure (e.g., −80 mmHg is more than −60mmHg).

The negative pressure range for some embodiments of the presentdisclosure can be approximately −80 mmHg, or between about −10 mmHg and−200 mmHg Note that these pressures are relative to normal ambientatmospheric pressure. Thus, −200 mmHg would be about 560 mmHg inpractical terms. In some embodiments, the pressure range can be betweenabout −40 mmHg and −150 mmHg Alternatively, a pressure range of up to−75 mmHg, up to −80 mmHg or over −80 mmHg can be used. Also in otherembodiments a pressure range of below −75 mmHg can be used.Alternatively, a pressure range of over approximately −100 mmHg, or even−150 mmHg, can be supplied by the negative pressure apparatus. In someembodiments, the negative pressure range can be as small as about −20mmHg or about −25 mmHg, which may be useful to reduce fistulas. In someembodiments of wound closure devices described here, increased woundcontraction can lead to increased tissue expansion in the surroundingwound tissue. This effect may be increased by varying the force appliedto the tissue, for example by varying the negative pressure applied tothe wound over time, possibly in conjunction with increased tensileforces applied to the wound via embodiments of the wound closuredevices. In some embodiments, negative pressure may be varied over timefor example using a sinusoidal wave, square wave, and/or insynchronization with one or more patient physiological indices (e.g.,heartbeat).

Examples of such applications where additional disclosure relating tothe preceding descriptions may be found include U.S. Pat. No. 8,235,955,titled “Wound treatment apparatus and method,” issued Aug. 7, 2012 andU.S. Pat. No. 7,753,894, titled “Wound cleansing apparatus with stress,”issued Jul. 13, 2010. Both applications are hereby incorporated byreference in their entirety. Other applications that may containteachings relevant for use with the embodiments described in thissection or elsewhere in this specification may include application Ser.No. 12/886,088, titled “Systems And Methods For Using Negative PressureWound Therapy To Manage Open Abdominal Wounds,” filed Sep. 20, 2010,published as US 2011/0213287; application Ser. No. 13/092,042, titled“Wound Dressing And Method Of Use,” filed Apr. 21, 2011, published as US2011/0282309; and application Ser. No. 13/365,615, titled “NegativePressure Wound Closure Device,” filed Feb. 3, 2012, published as US2012/0209227, the entireties of each of which are hereby incorporated byreference. Still more applications that may contain teachings relevantfor use with the embodiments described in this specification areapplication Ser. No. 13/942,493, titled “Negative Pressure Wound ClosureDevice,” filed Jul. 15, 2013, published as US 2014/0180225; PCT App. No.PCT/US2013/050619, filed Jul. 16, 2013 titled “Negative Pressure WoundClosure Device,” published as WO 2014/014871 A1; PCT App. No.PCT/US2013/050698, filed Jul. 16, 2013 titled “Negative Pressure WoundClosure Device,” published as WO 2014/014922 A1; PCT App. No.PCT/IB2013/01555, titled “Devices and Methods for Treating and ClosingWounds with Negative Pressure,” filed May 5, 2013, published as WO2013/175309 A1; PCT App. No. PCT/US2014/025059, titled “NegativePressure Wound Closure Device and Systems and Methods of Use in TreatingWounds with Negative Pressure,” filed Mar. 12, 2014, published as WO2014/165275 A1; and PCT App. No. PCT/GB2014/050746, “Compressible WoundFillers and Systems and Methods of Use In Treating Wounds With NegativePressure,” filed Mar. 13, 2014, published as WO 2014/140578 A1, and“Negative Pressure Wound Closure Device,” filed Oct. 21, 2014, andpublished as PCT/US2014/061627. The entireties of the aforementionedapplications are each hereby incorporated by reference and should beconsidered part of the present specification.

It will be understood that throughout this specification, in someembodiments, reference is made to an elongate, elongated or longitudinalstrip or strips. It is to be understood that these terms are to bebroadly construed and refer in some embodiments to an elongate materialhaving two parallel or substantially parallel faces, where incross-section a thickness of the material as measured perpendicular tothe faces is relatively smaller than a height of the material measuredparallel to the faces. While in some embodiments the strips may beconstructed from discrete lengths of material, in other embodiments thestrips may simply refer to elongate portions of an overall structurehaving two parallel or substantially parallel faces. The strips in someembodiments have a rectangular or generally rectangular-shaped faces,wherein a length of the face is longer than the height of the face. Insome embodiments, the length of the face may be more than 2 times, 4times, 6 times, 8 time, 10 times, 12 times or more greater than theheight of the face.

As used in this section or elsewhere in this specification, the term“horizontal,” when referring to a wound, indicates a direction or planegenerally parallel to the skin surrounding the wound. The term“vertical,” when referring to a wound, generally refers to a directionextending perpendicular to the horizontal plane. The term“longitudinal,” when referring to a wound, generally refers to adirection in the horizontal plane taken in a direction along which thewound is longest. The term “lateral,” when referring to a wound,generally refers to a direction in the horizontal plane perpendicular tothe longitudinal direction. The terms “horizontal,” “vertical,”“longitudinal” and “lateral” may also be used to describe thestabilizing structures and wound closure devices described throughoutthis specification. When describing these structures or devices, theseterms should not be construed to require that the structures or devicesnecessarily be placed into a wound in a certain orientation, though incertain embodiments, it may be preferable to do so.

FIG. 1 illustrates an embodiment of a negative pressure treatment system100 that comprises a wound packer 102 inserted into a wound 101. Thewound packer 102 may comprise porous materials such as foam, and in someembodiments, may comprise one or more embodiments of wound closuredevices described in further detail in this section or elsewhere in thisspecification. In some embodiments, the perimeter or top of any woundclosure device inserted into the wound 101 may also be covered with foamor other porous materials. A single drape 104 or multiple drapes may beplaced over the wound 101, and is preferably adhered or sealed to theskin on the periphery of the wound 101 so as to create a fluid-tightseal. An aperture 106 may be made through the drape 104 which can bemanually made or preformed into the drape 104 so as to provide a fluidicconnection from the wound 101 to a source of negative pressure such as apump 110. Preferably, the fluidic connection between the aperture 106and the pump 110 is made via a conduit 108. In some embodiments, theconduit 108 may comprise a RENASYS® Soft Port™, manufactured by Smith &Nephew. Of course, in some embodiments, the drape 104 may notnecessarily comprise an aperture 106, and the fluidic connection to thepump 110 may be made by placing the conduit 108 below the drape. In somewounds, particularly larger wounds, multiple conduits 108 may be used,fluidically connected via one or more apertures 106.

In some embodiments, the drape 104 may be provided with one or morecorrugations or folds. Preferably, the corrugations are aligned alongthe longitudinal axis of the wound, and as such may support closure ofthe wound by preferentially collapsing in a direction perpendicular tothe longitudinal axis of the wound. Such corrugations may aid in theapplication of contractile forces parallel to the wound surface and inthe direction of wound closure. Examples of such drapes may be found inapplication Ser. No. 12/922,118, titled “Vacuum Closure Device,” filedNov. 17, 2010 (published as US 2011/0054365), which is herebyincorporated by reference in its entirety.

In use, the wound 101 is prepared and cleaned. In some cases, such asabdominal wounds, a non- or minimally-adherent organ protection layer(not illustrated) may be applied over any exposed viscera. The woundpacker 102 is then inserted into the wound, and is covered with thedrape 104 so as to form a fluid-tight seal. A first end of the conduit108 is then placed in fluidic communication with the wound, for examplevia the aperture 106. The second end of the conduit 108 is connected tothe pump 110. The pump 110 may then be activated so as to supplynegative pressure to the wound 101 and evacuate wound exudate from thewound 101. As will be described in additional detail below and inrelation to the embodiments of the foregoing wound closure devices,negative pressure may also aid in promoting closure of the wound 101,for example by approximating opposing wound margins.

Any structure or component disclosed herein this section or elsewhere inthe specification may comprise a radiopaque material. A radiopaquematerial advantageously allows a clinician to more easily find pieces ofthe wound closure device that may have come loose from the structure andbecome lost in the wound. Some examples of radiopaque materials includebarium sulfate, bismuth trioxide, bismuth subcarbonate, bismuthoxychloride, and tungsten.

Stabilizing Structures and Wound Closure Devices of FIG. 2

FIG. 2 is a drawing of an embodiment of a stabilizing structure 2000comprising a plurality of elongate strips 2006 arranged in parallel orsemi-parallel, whose longitudinal length can be aligned with thelongitudinal axis of a wound. In embodiments, the elongate strips 2006may also be arranged in a non-parallel fashion. The various cells withinthis stabilizing structure 2000 may have a variety of shapes and sizes.As will be described in greater detail below, the length and shape ofthe elongate strips 2006, intervening members 2010, and cells 2004 maybe designed so as to facilitate greater closure of the stabilizingstructure. In certain embodiments, the junctions 2900 between theelongate strips and intervening members may be thinned to betterfacilitate rotation and closure of the stabilizing structures. In someembodiments, the stabilizing structure is tearable, such that thestructure may be shaped into the shape of a wound. As describedelsewhere in the specification, tears may be completed at theintersections between intervening members and elongate strips or at anysuitable location along the elongate strip or intervening member.

In some embodiments, the stabilizing structure 2000 may have an outerperimeter that defines an at least partially elliptical shape.Advantageously, the elliptical shape of stabilizing structure 2000 mayallow the structure to better accommodate the shape of the wound. Mostwounds are in shapes that are rounded, thus, an elliptically shapedstabilizing structure 2000 may better fit into a wound.

As described above, the stabilizing structure 2000 may comprise aplurality of cells 2004 provided side-by-side, each cell defined by oneor more walls, each cell having a top end and a bottom end with anopening extending through the top and bottom ends. As with the otherstabilizing structures described herein this section and elsewhere inthe specification, the stabilizing structure 2000 is configured tocollapse by collapsing one or more cells 2004. In some embodiments, thecells are all of the same approximate shape and size; however, in otherembodiments, the cells are of different shapes and sizes. In someembodiments, the stabilizing structures as described herein this sectionor elsewhere in the specification may be domed, such that the centralportion of the stabilizing structure bulges upward. For example, a lowerportion of the stabilizing structure may be concave, while an upperportion of the stabilizing structure is convex.

In certain embodiments, the stabilizing structure 2000 can collapse inany manner described in this section or elsewhere in this specificationwith or without the application of negative pressure. For example, thestabilizing structure may collapse significantly more in one plane thanin another plane upon application of negative pressure. In someembodiments, the stabilizing structure is configured to collapse more ina horizontal plane parallel to the length and width of the stabilizingstructure than in a vertical plane perpendicular to the horizontalplane. In embodiments, particular rows may collapse in a firstdirection, while another row may collapse in the same or an opposingdirection. In certain embodiments, the stabilizing structure maycollapse along the width of the stabilizing structure while remainingrelatively rigid along the length of the stabilizing structure and inthe vertical direction.

The stabilizing structure may be comprised of any materials described inthis section or elsewhere in this specification, including: flexibleplastics such as silicone, polyurethane, rigid plastics such aspolyvinyl chloride, semi-rigid plastics, semi-flexible plastics,biocompatible materials, composite materials, metals, and foam. Incertain embodiments, the stabilizing structure may comprise a radioopaque material, to more readily allow a clinician to find pieces of thestabilizing structure within the wound.

The stabilizing structure 2000 and all stabilizing structures and woundclosure devices described in this section or elsewhere in thisspecification can collapse on a variety of timescales in a dynamicfashion. In certain embodiments, the majority of the collapse may occurwithin the first few minutes upon application of negative pressure.However, after the initial collapse, the stabilizing structure or woundclosure device may continue to collapse at a much slower rate, therebyapplying increasing longitudinal tension over a long period of time anddrawing the edges of the wound closer together. By slowly drawing thewound edges closer together over time, the stabilizing structure orwound closure device allows the surrounding healing tissue to remodelsynergistically with the closure of the device or stabilizing structure.Slow, dynamic wound closure may allow the surrounding tissue to heal atan accelerated rate, because the collapsing structure or device slowlybrings the edges of the wound closer together without stressing thenewly formed or weakened tissue too quickly.

In some embodiments, the stabilizing structures described in thissection or elsewhere in this specification can be placed into a woundfor a period of time and then removed or replaced with anotherstabilizing structure. For example, a stabilizing structure could beinserted into a wound for a period of time, promoting closure of thewound by drawing the edges closer together. After a period of time haspassed, the stabilizing structure can be replaced by a stabilizingstructure of a different size or collapsibility, for example astabilizing structure of a smaller size or decreased density. Thisprocess could be repeated over and over, thereby continuously drawingthe edges of the wound together over time and allowing for continuingrepair and remodeling of the surrounding tissue. In certain embodiments,the stabilizing structure is configured to remain in the wound for atleast about less than 1 hour, at least about 1 hour, at least about 2hours, at least about 4 hours, at least about 6 hours, at least about 8hours, at least about 12 hours, at least about 24 hours, at least about2 days, at least about 4 days, at least about 6 days, at least about 1week, at least about 2 weeks, at least about 3 weeks, or more than 3weeks.

In certain embodiments, up to 90% of the collapse of the stabilizingstructure or wound closure device may occur within the first few minutesupon application of negative pressure, while the remaining 10% of thecollapse may occur slowly over a period of many minutes, hours, days,weeks, or months. In other embodiments, up to about 80% of the collapse,up to about 70%, up to about 60%, up to about 50%, up to about 40%, upto about 30%, up to about 20%, up to about 10%, or about 0% of thecollapse will occur immediately within the first few minutes uponapplication of negative pressure while the remainder of the collapseoccurs at a much slower rate such as over the course of many minutes,hours, days weeks, or months. In other embodiments, the stabilizingstructure can collapse at a variable rate. In some embodiments, theentirety of the collapse occurs at a slowed rate, while in otherembodiments the entirety of the collapse occurs almost immediatelywithin the first few minutes. In further embodiments, the collapse canoccur at any rate and the rate can vary over time. In certainembodiments, the rate of collapse can be altered in a variable fashionby adding and/or removing portions of the structure or by controllingthe application of negative pressure and irrigant fluid.

In some embodiments, the stabilizing structure 2000 of FIG. 2 can beconfigured to include perforations or detachable sections that allowportions of the device to separate from the remainder of the device. Forexample, perforations may be incorporated into the joints 2900 betweenvarious cells 2004 contained within the stabilizing structure 2000,allowing for the removal of individual rows or cells to alter the shapeof the stabilizing structure 2000.

Applicable to all stabilizing structures or wound closure devicesdescribed in this section or elsewhere in the specification, thestabilizing structure or wound closure device may be tearable such thatthe stabilizing structure may be shaped into the shape of a wound. Insome embodiments, the stabilizing structure may be torn at theintersections between intervening members and elongate strips, while infurther embodiments, the elongate strips or intervening members may betorn at any suitable position.

Wound Closure and Treatment Methods of FIGS. 3-10G

The stabilizing structures and/or wound closure devices described inthis section or elsewhere in this specification may be used inconjunction with methods or systems for the closure of a wound. In someembodiments of methods of use for closure of a wound, one or more of thestabilizing structures or wound closure devices of any of theembodiments described in this section or elsewhere in this specificationis placed into a wound. In some embodiments, an organ protection layermay be provided in the wound before placement of the stabilizingstructure. In certain embodiments, foam or other porous material may beplaced in the wound along with the stabilizing structure or woundclosure device, either below, above, or surrounding the stabilizingstructure or wound closure device. Foam or other porous material mayalso surround the perimeter of the stabilizing structure or woundclosure device. The stabilizing structure or wound closure device may beconfigured to collapse in any manner as described in this section orelsewhere in this specification, for example by having a particular sizeand shape, or by comprising a certain volume of foam or other porousmaterial within the cells of the structure. The stabilizing structure orwound closure device may further be altered in any manner described inthis section or elsewhere in this specification so as to betteraccommodate the shape of the wound. After placement in the wound, thestabilizing structure or wound closure device can be sealed by afluid-tight drape. The fluid-tight drape can comprise a port configuredfor the application of negative pressure. A source of negative pressuremay then be connected to the port and negative pressure may be appliedto the wound. The stabilizing structure or wound closure device may bereplaced over time by stabilizing structures or wound closure devices ofvarious shapes and sizes as desired to best promote wound healing.

FIGS. 3-10G are photographs and illustrations depicting embodiments ofmethods for the treatment of a wound that utilize a wound closure devicecomprising a stabilizing structure as described herein this section andelsewhere in the specification. To better illustrate non-limitingembodiments of the methods, numbers have been added to the steps of FIG.10 to allow the reader to more easily follow these steps of the method.However, the steps can be performed in any order, and any numberingsystem is for clarity only. Further, in some embodiments, differentsteps of these methods may be excluded. In other embodiments, additionalsteps may be added to the methods based on methods described herein thissection and elsewhere in the specification. The porous layers andstructures described in this section may be of any material or structuredescribed elsewhere in the specification, such as foam.

FIG. 3 depicts an embodiment of an open wound 3100 prior to treatmentwith a wound closure device as will be described in much greater detailbelow. The open wound of FIG. 3 is similar to the wounds describedelsewhere in the specification, particularly as relate to FIG. 1. Insome instances, as described elsewhere in the specification, such awound may be produced via a surgical incision or other means.

FIG. 4 depicts an embodiment of an initial step in a method for thetreatment of an open wound 3100 with a wound closure device. Beforetreatment, the wound may be cleaned with a pad 3180 and the skin 3190prepared for application of a wound closure device, such as thosedescribed in relation to FIG. 2.

FIG. 5 depicts an embodiment of an early step in a method for thetreatment of an open wound 3100. In some embodiments, a tissueprotection layer 3170 may be placed over the wound to protect theunderlying tissues from the rigors of negative pressure wound therapy orother potential harms. Accordingly, certain embodiments provide for atissue protection layer 3170 which may be cut to size to be placed overthe wound site 3100. The tissue protection layer 3170 can be a materialwhich will not adhere to the wound site or to the exposed viscera inclose proximity. Such a tissue protection layer may be constructed fromany suitable material such as a biocompatible polymer. For example,organ protection layers manufactured by Smith & Nephew and sold underthe brand RENASYS® may act as tissue protection layers and be placedover the abdominal cavity and/or wound bed 3100 and tucked over theperitoneal gutter. In further examples, materials such as thefluoropolymer polytetrafluoroethylene (PTFE) may be applicable as thesematerials are generally non-adherent and used in surgical grafts. In oneembodiment, the tissue protection layer is permeable. For example, thetissue protection layer 3170 can be provided with openings, such asholes, slits, or channels, to allow the removal of fluids from the woundsite 3100 or the transmittal of negative pressure to the wound site3100. In further embodiments, the tissue protection layer may be usedover non-abdominal wounds on other areas of the body, such as the leg,arm, shoulder, or back. In certain embodiments, the tissue protectionlayer may comprise a sensor configured to measure pressures in andaround the wound. For example, the sensor may be used to measure thelevel of negative pressure applied to the wound or to measure thepressure on the underlying organs beneath the abdominal wound.

FIGS. 6A-B illustrate embodiments of possible initial steps in a methodfor the treatment of an open wound. However, as described above, thesteps need not be performed in this order and may be performed in anyorder. In FIG. 6A, two pieces of a porous material such as foam, abottom piece 3102 and a top piece 3116 are selected so as to approximatethe size of the wound 3100. In some embodiments, the top piece and thebottom piece are of identical thickness. However, in certainembodiments, and vice-versa, top piece 3116 may be at least twice asthick, at least four times as thick, at least 10 times as thick or morethan ten times as thick as bottom piece 3102. Bottom piece 3102 may beshaped via cutting or other suitable means to the shape of the wound andsubsequently placed into the wound 3100, as shown in FIG. 6B anddepicted further below in FIGS. 7A-B.

FIGS. 7A-B are photographs of a foam layer 3102 (for example, a 15 mmlayer of foam), after shaping, placed into a wound bed 3100. In FIGS.8A-C, a stabilizing structure 3104 similar to the stabilizing structuresdisclosed in FIGS. 2-3 or any other stabilizing structure describedelsewhere in the specification, is in the shape of the wound. Thestabilizing structure may be shaped into the shape of the wound viacutting or other suitable means or the stabilizing structure mayinitially be of a size that is readily accommodated by the wound. Asdisplayed in FIG. 8B, the stabilizing structure 3104 may be placed intothe wound. To assist with the insertion of the device into the woundbed, the device can be deformed slightly inwardly or horizontally tofacilitate entrance into the wound site. In some embodiments, the devicemay be squeezed slightly during insertion and then release upon contactwith the walls of the wound. In certain embodiments, the wound closuredevice 3104 may be placed such that the longitudinal sides of the matrixalign with the longitudinal axis of the wound 3100. Continuing with FIG.8B, another foam layer 3116 (for example, a 10 mm layer of foam) isplaced on top of the wound closure device 3104.

FIG. 8C is a photograph of application of a port 3122 to the stabilizingstructure and foam of FIGS. 8A-B. A bridging portion of foam 3118 may beplaced in intimate contact with the foam layer 3116 at the edge of thewound. The bridging portion of foam 3118 may extend over intact skin,with a piece of drape 3120 placed between it and the intact skin.Further, a suction port 3122 may be connected to the bridging portion3118 with a section of drape 3120 between. In alternative embodiments,the bridging portion 3118 and suction port 3122 may be placed on thewound during a different step depicted in FIGS. 7A-8B.

In FIG. 9, as shown by steps 1-4, the device may be covered by one ormore drapes 3120. A hole may be made in the drape covering the bridgingportion of foam, and a suction port 3122 may be placed over the hole. Aprotective layer 3124 on the top surface of the one or more drapes maybe removed after the drapes 3120 are applied. Once the drapes 3120 areapplied and the port is in place, negative pressure may be applied tothe wound through the drape from a vacuum source. The negative pressurecan cause the stabilizing structure to collapse horizontally asdescribed elsewhere in this specification. Tissue anchors which areadhered to the stabilizing structure through the porous layer may engagetissue of the wound and may facilitate closure of the wound.

In certain embodiments, the suction port may be placed directly over thecentral portion of the foam layer 3116. In such embodiments, the foamlayer may collapse inward along with the stabilizing structure whileunder negative pressure, thereby collapsing the suction port. To avoidcollapse, the suction port may be rigid in comparison to the foam andresist collapse. A washer may be placed inside, below, or around thesuction port to provide rigidity and resist collapse.

In some embodiments, the suction port may be pre-attached to the topfoam layer so that drapes can be positioned around the port. A hard portor a soft port may be used, such ports may further be used incombination with a washer such as described above. In furtherembodiments, the suction port could only partially collapse with thecollapsing matrix while still maintaining the port opening for negativepressure.

FIGS. 10A-C provide further illustrations of an upper foam layer 3116being placed in a wound, followed by placing a bridging portion 3118 andplacing one or more drapes or wound covers 3120. FIGS. 10D-10Gillustrate an embodiment of several steps in a method for the treatmentand closure of a wound. As illustrated in FIG. 10D, a suction port 3122is separated from a release liner 3126 and later applied to a wound asdepicted in FIGS. 7A-9. FIG. 10E illustrates a canister 3128 beinginserted into a negative pressure wound therapy device 3130 inpreparation for the collection of wound exudate. FIG. 10F illustratesthe snap connection between the tubing connected to the suction port andthe tubing connected to the negative pressure wound therapy device 3130.Once the connection has been made, negative pressure wound treatment maybegin as depicted in FIG. 10G.

Further details regarding the wound closure devices, stabilizingstructures, related apparatuses and methods of use that may be combinedwith or incorporated into any of the embodiments described herein arefound elsewhere throughout this specification and in InternationalApplication No. PCT/US2013/050698, filed Jul. 16, 2013, published as WO2014/014922 A1, the entirety of which is hereby incorporated byreference.

Wound Closure Devices of FIGS. 11A-12

As discussed elsewhere in the specification, wound closure devices,stabilizing structures, and foam or porous materials may be shaped intothe shape of a wound such that they can better accommodate the wound.Even if a stabilizing structure, foam or any porous material is not forinsertion into a wound, it may be advantageously shaped into desirablesize and shape to better serve its purpose. As discussed elsewhere inthe specification, in some embodiments, wound closure devices,stabilizing structures, or foam or porous materials may be pre-shapedinto any common shapes of wounds, such as an elliptical shape, and/orcan be cut or tearable from a larger structure, such that the structuremay be shaped into the shape of a wound. However, in some embodiments,any wound closure devices, stabilizing structures and/or foam/porousmaterials may be built from smaller building blocks, units or modules toform structures with desirable shapes. When structures or devices arebuilt from smaller building blocks, they may be advantageouslydisassembled and/or reassembled to form another structures or deviceswith different shapes or sizes.

FIG. 11A illustrates an embodiment of building blocks 4000 that may beused to assemble stabilizing structures, foams or any other woundclosure devices similar to those described in this specification. Insome embodiments, the building blocks 4000 may be building blocks usedto assemble for stabilizing structures having a size, shape and/orconfiguration similar to those illustrated in FIGS. 2, 8A or 8B. Asillustrated in FIG. 11A, one or more building blocks 4000 may have ahexagonal shape. In some embodiments, one or more building blocks 4000may have a diamond shape, a square shape, a rhombus shape, anyquadrilateral shape, any hexagonal shape, a triangular shape, or anyother suitable shapes.

As illustrated in FIG. 11A, each of the building blocks 4000 may bedefined by one or more walls and have a top end and a bottom end with anopening extending through the top and bottom ends, such that each of thebuilding blocks 4000 become a cell when assembled to form a stabilizingstructure. In some embodiments, the building blocks 4000 may be providedto have more than one cell for stabilizing structures, for example two,three, four, five or more cells, such that stabilizing structures can bebuilt from building blocks having multiple cells.

Even though the illustrated building blocks 4000 are similar to cells ofstabilizing structures described in this section or elsewhere in thespecification, features and teachings described in relation to FIGS.11A-C may be applicable to foam or porous materials/layers or any othercomponents of wound closure devices described in this section orelsewhere in the specification. For example, in some embodiments, thebuilding blocks 4000 may rather comprise a foam or porous material, suchthat it forms a larger foam or porous material structure or layersimilar to those described in this section or elsewhere in thespecification.

The building blocks 4000 may be constructed from any materials ormethods described in relation to stabilizing structures or foamlayer/structures, for example, flexible plastics such as silicone,polyurethane, rigid plastics such as polyvinyl chloride, semi-rigidplastics, semi-flexible plastics, biocompatible materials, compositematerials, metals, and foam.

One or more building blocks may be adhered to one another via adhesive,Velcro®, or other suitable adhesive means. In some embodiments, magnetsand/or suction cups may be used to keep the segments together. In someembodiments, one or more building blocks may have one or more attachmentelements and/or one or more receiving elements. The attachment elementsmay be configured to serve to maintain attachment of a building block toanother block until the attachment elements are separated from thereceiving elements, for example by applying suitable force. Attachmentelements may be prongs, hooks, tongues, screws, nails, or other suitableattachment means, and/or receiving elements may be in form of grooves,holes, windows, or any suitable means. For example, FIG. 12 illustratesan embodiment of part of building blocks 5200 and 5400 being reversiblyattached to each other. The building block 5200 may have a receivingelement 5220 while the building block 5400 may have an attachmentelement 5440 which is configured to fit into the receiving element 5220.In certain embodiments, each of building blocks may comprise bothattachment elements and receiving elements. Building blocks may beassembled in a vertical direction, a horizontal direction, or both.

Turning back to FIGS. 11A-C, multiple building blocks 4000 may beadhered to one another side-by-side to provide a stabilizing structureor a foam or porous structure/layer, such as described in this sectionor elsewhere in the specification. FIGS. 11B-C illustrate such anembodiment of a stabilizing structure constructed from building blocks4000. As shown in FIGS. 11B-C, by assembling building blocks 4000 indifferent ways, different structures may be provided. For example, thestructure 4200 has approximately diamond shape, while the structure 4400has approximately square shape. The structure 4200 may better fit to awound having a length greater than a width, while structure 4400 maybetter fit to a wound having a width greater than a length. In someembodiments, one structure provided by assembling building blocks can betransformed to provide another structure with different size or shape bydissembling and reassembling building blocks. For example, a clinicianmay transform the structure 4200 into the structure 4400, or vice versa,by rearranging and/or adding/removing the building blocks 4000.

Wound Closure Devices of FIGS. 13A-14E

In some embodiments, stabilizing structures or foams may be provided ascustomizable building units having relatively simple shapes, (e.g., asingle-row elongate structure, a square, a hexagon, etc.) which arecustomizable into different building units and/or assemble-able. Unlikebuilding blocks described in relation to FIGS. 11A-C, customizablebuilding units can be severed and customized into building units havingdifferent shape or size to be assembled to form stabilizing structuresor foams. For example, each of customizable building units may havemultiple reversibly-detachable cells or blocks, such that one can detachcertain cells or blocks to transform the customizable building unitsinto different building unit, and optionally assemble transformed unitstructures to make a stabilizing structure or foam having desired sizeand/or shape. In some embodiments, customizable building units areprovided in uniform size and shape, such that it can be produced orpackaged more efficiently, while it can be easily customized.

Stabilizing structures FIGS. 13A-B illustrates an embodiment of anelongate single-row customizable building unit 6000 including a centralblock or cell 6002 and a plurality of peripheral blocks or cells 6004provided side-to-side in a single row. FIG. 13A-B illustrates aperspective view and a top view of the customizable building unit 6000,respectively. The illustrated embodiment of the customizable buildingunit 6000 may be similar with stabilizing structures described elsewherein the specification, and blocks or cells 6002, 6004 may be similar withcells of the stabilizing structures, such that they are defined by oneor more walls and each block or cell has a top end and a bottom end withan opening extending through the top and bottom ends. However, in someembodiments, the customizable building unit 6000 may be similar withfoams or porous structures described elsewhere in the specification suchthat the top end and the bottom end do not have openings extendingthrough the top and bottom ends. Even though the customizable buildingunit 6000 is illustrated to be similar with stabilizing structuresdescribed in this section or elsewhere in the specification, featuresand teachings described in relation to FIGS. 13A-F may be applicable tocustomizable building units similar to foam or porous materials or anyother components of wound closure devices described in this section orelsewhere in the specification.

As illustrated in FIGS. 13A-B, the central cell 6002 and peripheralcells 6004 may have hexagonal shapes. In some embodiments, cells mayhave a diamond shape, a square shape, a rhombus shape, any quadrilateralshape, any hexagonal shape, a triangular shape, or any other suitableshapes. In some embodiments, the central cell 6002 and peripheral cells6004 may have different shapes, such as shown in FIGS. 13A-B. In someembodiments, the central cell 6002 and peripheral cells 6004 may have auniform shape. In some embodiments, peripheral cells 6004 may have sameshape and sizes such that they are interchangeable. In some embodiment,peripheral cells 6004 may have two or more different shapes or sizes.

The customizable building unit 6000 may comprise pre-cuts defining cells6002 and 6004, such that each cell can be easily disassembled, cut outor torn to reduce its length. In some embodiments, the unit 6000 may beconstructed by assembling each of cells 6002 and 6004. Cells 6002 and6004 may be attached with adhesives, Velcro®, other mechanical means, orany other suitable means such as described in more details below. Cells6002 and 6004 may be reversibly detachable such that cells 6002 and 6004may be disassembled without substantially damaging any part of cells,for example by application of force.

In some embodiments, the length of single-row building units such as thecustomizable unit 6000 may be adjusted by adding/removing peripheralcells 6002. FIG. 13C illustrates single-row building units 6020 and 6040similar to the unit 6000, but having fewer numbers of blocks or cells.The building units 6020 and/or 6040 may be prepared by removingperipheral cells 6004 from the customizable building unit 6000 of FIGS.13A-B. In some embodiments, shorter units may be prepared by removingone, two, three, four, five, or more peripheral cells 6004 from a longerunit. Alternatively, the building units 6020 and 6040 may be constructedby assembling cells 6002 and 6004. The shortest unit 6040 may be thecentral cell 6002.

The building units 6020 and 6040 provided by adjusting the customizablebuilding unit 6000 may be assembled to provide a more complex structure.FIG. 13D illustrates an embodiment of a collection of single-rowbuilding units 6000, 6020, and 6040 having different lengths, arrangedin an approximately diamond shape before assembly. FIGS. 13E-Fillustrate a multi-row structure 6500 formed by assembling the buildingunit 6000 and two of each of the building units 6020 and 6040 asarranged in FIG. 13D. By assembling multiple single-row units, one mayincrease the width of the structure. The illustrated multi-row structure6500 has approximately a diamond shape. In some embodiments, themulti-row structure 6500 may have approximately an elliptical shape, acircular shape, or any other shapes. In some embodiments, the multi-rowstructure 6500 may be a stabilizing structure similar to stabilizingstructures described in this section or elsewhere in the specification,such that it collapses by collapsing one or more cells.

In some embodiments, a clinician may decrease the size of the multi-rowstructure 6500 as the size of the wound decrease as the wound heals. Insome embodiments, a kit may include multiple customizable single-rowunits, such that a clinician can freely attach and/or detach cells ofsingle-row units, and freely attach and/or detach multiple single-rowunits to accommodate various size and shape of the wound. Interfacebetween each cell and each single-row unit may comprise means toreversibly attach cells and structures, such as Velcro®, adhesives,anchors, hooks, prongs or any other suitable means, such as described inthis section or elsewhere in the specification. In some embodiments, thesingle-row unit 6000 may be replaced with any other structures havingcells or blocks.

FIGS. 14A-B illustrate a customizable single-row building unit 7000similar to the single-row building unit 6000 shown in FIGS. 13A-B. Thebuilding unit 7000 contains a plurality of cells or blocks 7002 providedside-by-side. One or more cells or blocks 7002 may have a same size andshape. In some embodiments, all cells or blocks 7002 have same shapeand/or size. Each of cells or blocks 7002 may have a diamond shape suchas shown in FIGS. 14A-B. In some embodiments, cells or blocks 7002 mayhave a hexagonal shape, a square shape or any other suitable shapes. Thebuilding unit 7000 may comprise precuts defining cells 7002.

FIG. 14C illustrates single-row building units 7100, 7200, and 7300which may be provided from the customizable unit 7000 by methods similarto those described in relation to FIGS. 13A-C, for example tearing alongprecuts defining cells 7002. FIG. 14D illustrates single-row buildingunits 7110, 7210, and 7310 which mirrors the units 7100, 7200, and 7300respectively. The units 7110, 7210, and 7310 may be provided by flippingthe units 7100, 7200, and 7300 upside-down, respectively.

FIGS. 14E-F illustrate an embodiment of a multi-row structure 7500,which may be provided by adhering the building units 7100, 7200, 7300,7110, 7210, and 7310 by methods described in this section or elsewherein the specification. FIG. 14E illustrates a plan view of the structure7500 from the top. As shown in FIG. 14E, single-row units may beassembled to provide the structure 7500 such that cells may be angled inalternative directions, all in one direction on a side of a midline7550, and all in another direction on the other side of the midline7550. FIG. 14F is a perspective view of the structure 7500. FIG. 14Gillustrates a plan view of an embodiment of a multi-row structure 7700,which also may be provided by adhering the building units 7100, 7200,7300, 7110, 7320, and 7310 similarly to the structure 7500, but in adifferent configuration. As shown in FIG. 14G, single-row units may beassembled to provide the structure 7700 such that cells may be angled inalternative directions, all in one direction on a row, and all inanother direction on the adjacent row(s).

Wound Closure Devices of FIGS. 15A-B

As described in relation to FIGS. 13A-14E, stabilizing structures orfoam structure/layers may be constructed from customizable buildingunits comprising detachable blocks or cells. Even though FIGS. 13A-14Eillustrates cells or blocks similar to cells of stabilizing structures,features described in relation to FIGS. 11A-14E may be applied to foamor porous structures or layers. In some embodiments, customizablebuilding units for foam structure/layer may not have cell-like features,for example because foam structure or layer does not need to have cells,and customizable building units may be customized by freely tearing orcutting parts along the units.

FIG. 15A illustrates such an embodiment of elongate customizablebuilding units 8000. Each of the building units 8000 may contain foam orporous material 8020, and attachment sections 8040 and 8060. Thebuilding units 8000 may be adhered to one another by attaching thesection 8040 of one unit to the section 8060 of another unit. Sections8040 and sections 8060 may be configured to be reversibly attached toeach other by any means described in this section or elsewhere in thespecification, for example, by Velcro®, adhesives, anchors, hooks,prongs or any other suitable means. The length and shape of each of thebuilding units 8000 may be adjusted by tearing or cutting. In someembodiments, each of the building units 8000 may comprise precuts suchthat each of the building units 8000 may be torn along precuts.

FIGS. 15B illustrates a foam structure 8500 built from multiple unitswhich are adjusted from the customizable building units 8000 to havedifferent lengths, and adhered to one another side-by-side. The foamstructure 8500 may have an at least partially elliptical shape. In someembodiments, the structure 8500 may have at least approximately diamondshape, a square shape, a rectangular shape, or any other suitable shapesto better accommodate to a wound. In some embodiment, the size of thefoam structure may be adjusted by removing and/or adding building units.For example, the width of the structure 8500 may be reduced by removingunits 8520 and re-assembling the rest of the structure 8500.

Other Variations

Although this disclosure describes certain embodiments, it will beunderstood by those skilled in the art that many aspects of the methodsand devices shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure.Indeed, a wide variety of designs and approaches are possible and arewithin the scope of this disclosure. No feature, structure, or stepdisclosed herein is essential or indispensable. Moreover, whileillustrative embodiments have been described herein, the scope of anyand all embodiments having equivalent elements, modifications,omissions, combinations (e.g., of aspects across various embodiments),substitutions, adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. While certainembodiments have been described, these embodiments have been presentedby way of example only, and are not intended to limit the scope ofprotection.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of asubcombination.

Moreover, while operations may be depicted in the drawings or describedin the specification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, or thatall operations be performed, to achieve desirable results. Otheroperations that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionaloperations can be performed before, after, simultaneously, or betweenany of the described operations. Further, the operations may berearranged or reordered in other implementations. Those skilled in theart will appreciate that in some embodiments, the actual steps taken inthe processes illustrated and/or disclosed may differ from those shownin the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure. Also, theseparation of various system components in the implementations describedabove should not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. Not necessarily all such advantages maybe achieved in accordance with any particular embodiment. Thus, forexample, those skilled in the art will recognize that the disclosure maybe embodied or carried out in a manner that achieves one advantage or agroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements, and/or steps areincluded or are to be performed in any particular embodiment.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

The scope of the present disclosure is not intended to be limited by thespecific disclosures of preferred embodiments in this section orelsewhere in this specification, and may be defined by claims aspresented in this section or elsewhere in this specification or aspresented in the future. The language of the claims is to be interpretedbroadly based on the language employed in the claims and not limited tothe examples described in the present specification or during theprosecution of the application, which examples are to be construed asnon-exclusive.

1. A wound closure device comprising: a plurality of building blocksand/or building units configured to be adhered to or attached to eachother to form an assembled structure for insertion into or placementover a wound.
 2. The wound closure device of claim 1, wherein each ofthe building blocks and/or building units comprises at least one cell.3. The wound closure device of claim 1, wherein the building blocksand/or building units are configured to form an assembled stabilizingstructure comprising a plurality of cells defined by one or more walls,wherein in the assembled stabilizing structure cells are providedside-by-side in a horizontal plane and each of the cells has a top endand a bottom end with an opening extending through the top and bottomends.
 4. The wound closure device of claim 1, wherein the plurality ofbuilding blocks and/or building units are configured to be reversiblyadhered to one another.
 5. The wound closure device of claim 1, whereinone or more of the building blocks and/or building units comprisesattachment elements.
 6. The wound closure device of claim 5, wherein oneor more of the building blocks and/or building units comprises receivingelements configured to receive the attachment elements of one or more ofthe building blocks and/or building units.
 7. The wound closure deviceof claim 1, wherein one or more of the building blocks and/or buildingunits has an elongate shape with a uniform width.
 8. The wound closuredevice of claim 1, wherein each of the building blocks and/or buildingunits comprises one or more cells provided in a single row. 9.(canceled)
 10. (canceled)
 11. The wound closure device of claim 1,wherein each of the building blocks and/or building units comprisescells having a uniform shape and size.
 12. The wound closure device ofclaim 1, wherein each of the building blocks and/or building unitsconsists of one cell.
 13. The wound closure device of claim 1, whereineach of the building blocks and/or building units comprises at least onecell having a triangular, quadrilateral or hexagonal shape.
 14. Thewound closure device of claim 1, wherein each of the building blocksand/or building units comprises foam or porous material.
 15. The woundclosure device of claim 14, wherein one or more building blocks and/orbuilding units further comprises precuts defining frangible portions ofthe foam or porous material.
 16. The wound closure device of claim 1,wherein one or more of the plurality of building blocks and/or buildingunits is configured to be cut or torn.
 17. The wound closure device ofclaim 1, further comprising a source of negative pressure.
 18. The woundclosure device of claim 1, further comprising a drape.
 19. The woundclosure device of claim 18, further comprising a port, wherein the portis configured to transmit negative pressure through a drape placed overthe wound.
 20. The wound closure device of claim 1, further comprisingan organ protection layer.
 21. A method of treating a wound, comprising:adhering a plurality of building blocks and/or building units to oneanother to provide a stabilizing structure; inserting the stabilizingstructure into the wound; wherein the plurality of building blocksand/or building units comprise one or more cells, wherein the pluralityof building blocks and/or building units are configured to be adhered toone another to provide the stabilizing structure.
 22. (canceled)
 23. Themethod of claim 21, further comprising adjusting the size and/or shapeof the building blocks and/or the building units by detaching one ormore cells from the building blocks and/or the building units, whereinone or more units have two or more cells.
 24. (canceled)
 25. (canceled)26. (canceled)
 27. (canceled)
 28. (canceled)
 29. (canceled) 30.(canceled)